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Initial Submission for Review of Clinical Research
 
As of April 1, 2014, all submissions to the REB are submitted electronically through Romeo. If you have not received Romeo training, please email Elizabeth Gillis. To access Romeo, please use your user name and password.
 
Instructions for Application to the Full Board
  1. Applications are due by 12:00 noon on the 3rd Tuesday of every month. The REB meets the first Wednesday of every month to review the submissions. In most instances, the CHEO Site Investigator, CHEO co-investigators and their research coordinator will be invited to attend a board meeting of the REB to discuss their project.
  2. The number of protocols reviewed per month is limited to ensure thorough review of each application. Protocols are generally reviewed on a first–come first–served basis, although priority may be given to a proposal because of mitigating circumstances (e.g., the protocol offers treatment that would not be available otherwise and is considered urgent).
  3. Incomplete submissions will NOT be accepted. Investigators will be notified by email when an application is incomplete. 
  4. The turnaround time for submissions that require review by the full Board is approximately four (4) weeks from the date of submission.
  5. Complete instructions for these submissions can be found in the applications guidelines for protocols reviewed by the full board.
  6. Applications are to be submitted using Romeo.
  7. An acknowledgement email will be sent to investigators once an application has been successfully submitted to and accepted by the REB.
 
Instructions for Investigational Device Projects
Projects that include only a Class II, Class III or Class IV device  (i.e., does not include an investigational drug, biologic or NHP) should be submitted using the investigational device projects application.  The review stream (Full Board or Delegated) of these studies will be determined on a case-by-case basis, however typically a class II device will be reviewed in the minimal risk delegated review stream.  The Research team will be notified by the REB office which stream the study will be reviewed under. This decision is based on the determination of risk (i.e., greater than minimal risk or equal to/less than minimal risk).
 
 
Instructions for Delegated Research Protocols

Protocols that present only minimal or very low risk to participants are reviewed by the Chair and/or delegate. Minimal or low risk is ordinarily taken to mean those risks normally encountered in everyday life by the research participant.

There are four (4) streams of delegated review:
  • Research projects involving minimal risk that proposes a prospective collection of data involving children, families and/or staff. The appropriate authorization from the manager responsible for the staff or the clinical population involved in the study is required. Complete the application for Prospective Studies involving Minimal Risk (e.g.; Surveys, Quality of Life Questionnaires, Non-Invasive Procedures) in Romeo.
  • Retrospective chart reviews or secondary use of clinical data - complete the application for Retrospective Chart Review or Secondary Analyses of Clinical Samples in Romeo.
  • Databases - complete the application for Prospective Studies Involving Minimal risk in Romeo.
  • Record Level Requests from the BORN Datasets - complete the application in Romeo.
  • Prescribed Entity or Prescribed Registry  - complete the application in Romeo.
  1. There are no submission deadlines for delegated reviews; they can be submitted at any time in Romeo.
  2. The turnaround time upon receipt of a complete application that undergoes delegated review is minimally six (6) weeks. 
  3. Submissions that are incomplete or require modifications will delay this process. Incomplete submissions will NOT be accepted. Investigators will be notified by email when an application is incomplete.
  4. An acknowledgement email will be sent to investigators once an application has been successfully submitted to and accepted by the REB.
 
 
 
 
External Support resources
CRU ethics facilitator
Support and guidance prior to and during the REB review process
Chantal Horth
Request a consultation
 
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